iSite
A Randomized Trial of Intra-Portal Alone Versus Intra- and Extra-Portal Transplantation of Pancreatic Islets After Total Pancreatectomy for Chronic Pancreatitis
Sponsor study identifier
interventional
23
1 country
1
Study Start
August 1, 2019
Actual (reported)Primary Completion
December 31, 2024
Actual (reported)Study Completion
December 31, 2024
Actual (reported)Randomized pilot trial of patients (n=30) undergoing Total Pancreatectomy and Islet AutoTransplant (TPIAT). Patients with islet harvest of greater than 5000 islet equivalents/kg body weight will be randomized to receive a portion of their islets into an omental pouch. For outcomes related to islet function, a group of normal volunteers (n=15) will be studied as a comparator group.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 5, 2018
Actual (reported)December 19, 2018
Actual (reported)August 1, 2019
Actual (reported)December 31, 2024
Actual (reported)December 31, 2024
Actual (reported)Portal vein thrombosis
Portal vein thrombosis is associated with higher tissue volume infused into the portal vein and higher portal pressures and is assessed using abdominal ultrasound.
Post operative day 4 or 5.
Clavien-Dindo classification of surgical complications
Grades surgical complications based on the level of treatment necessary to treat the complication.
Within 30 days of surgery
Mixed Meal Tolerance Test
Patient is given Boost HP (6cc/kg), ingested 5 minutes after t=0 blood draw. Blood is drawn every half hour for 2 hours.
1 year
Intravenous Glucose tolerance test
Patients are given a bolus of 0.2mg/kg of dextrose at t=0. Blood samples will be drawn at t=-10,-5,-1,2,3,4,5,7 and 10 minutes
1 year
Patients with islet harvest of \>5000 islet equivalents per kg body weight will be randomized in a 1:1 ratio to 4000 IEq/kg delivered via intraportal route and the remainder implanted into a constructed omental pouch.
This is the standard of care procedure. Patients with islet harvest of \>5000 islet equivalents per kg body weight will be randomized in a 1:1 ratio to all islets autotransplanted intrahepatically via the intraportal route.
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Greg Beilman, MD
University of Minnesota, Department of Surgery
23 participants (actual enrollment reported by the registry).
First Submitted
November 5, 2018
First Posted
December 19, 2018
Study Start
August 1, 2019
Actual (reported)Dexcom G6 Intervention Study
Glucose potentiated arginine stimulation
Starting immediately after glucose tolerance test (time t=10 minutes), 20% dextrose will be infused to maintain a glucose \~230mg/dL until test is completed. Glucose levels are measured every 5 minutes to maintain glucose in the target range after 40 minutes of continuous 20% dextrose infusion, After 40 minutes of continuous D20% infusion, baseline samples for glucose, insulin, and C-peptide are drawn (three samples over 10 minutes), a bolus of 5 grams arginine is given (at time 55 minutes), and samples for glucose, insulin, and C-peptide are taken at 2, 3, 4, and 5 minutes after the arginine bolus.
1 year
Hypoglycemic clamp
A stepped hypoglycemic clamp protocol with variable glucose infusion rates will be performed to achieve 45 min glucose plateaus at 70, 60, and 50 mg/dl.Glucagon responses will be calculated by subtracting the mean of the three baseline values observed prior to the clamp from glucagon levels observed at 70, 60, and 50 mg/dl glucose nadirs during the clamp
1 year
Continuous glucose monitoring
3 days of CGM monitoring at one year will be obtained for mean glucose,standard deviation, and percent of time in hypo- and hyperglycemia
1 year
Hemoglobin A1c levels
Measure of average glucose levels over last several weeks
1 year
Insulin Use
calculated as units/kg/day, will be assessed from glucose and insulin diaries maintained by patients for 14 days, overlapping with day 90
1 year
Hypoglycemic episodes
All severe hypoglycemic events will be recorded. This is defined based on American Diabetes Association criteria as a hypoglycemic episode \<54 mg/dL or (if not measured) associated with prompt recovery upon administration of glucose in which a patient is mentally or physically incapacitated and requires assistance from another person to treat the hypoglycemia.
1 year
Clarke score
is determined from eight questions characterizing the participant's exposure to episodes of moderate and severe hypoglycemia; it evaluates symptomatic responses to hypoglycemia. A score of 4 or greater suggests impaired awareness of hypoglycemia
1 year
These individuals will undergo metabolic testing as well as islet cell function testing.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
December 31, 2024
Actual (reported)Study Completion
December 31, 2024
Actual (reported)Last Updated
January 27, 2025
Record last verified: 2025-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: